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First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers

NCT02334449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2016-10-27

No results posted yet for this study

Summary

Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers

Conditions

  • Healthy Volunteers

Interventions

DRUG

LML134

LML134 will be administered first as single doses and then as multiple doses

DRUG

Placebo

All study cohorts (except food effect cohort) are placebo controlled

Sponsors & Collaborators

Principal Investigators

  • Study Director · Novartis Pharmceuticals

Study Design

Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334449 on ClinicalTrials.gov